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16 Oct 2013,
Erik Vollebregt
This seminar addressed how to develop compliant medical software and how to prepare for increased scrutiny by the authorities. Speakers and their presentations: Robert Houtenbos, mHealth consultant How to design medical software…

Article

19 Mar 2012,
Erik Vollebregt
The ongoing EU MEDDEV bonanza that started this January has produced yet another new document, in this case a new version of the MEDDEV 2.12/1 Medical devices vigilance system, now at revision 7….

Article

17 Jan 2012,
Erik Vollebregt
The EU just released its first MEDDEV of a number that were agreed upon in the recent MDEG meeting. More are expected to trickle onto the Commission’s devices web pages in the coming…

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19 Sep 2011,
Erik Vollebregt
Important developments for the medical devices and medicinal products industry: clarification of EU law about the borderline between these groups of products is currently in the making at the European Court of…

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14 Dec 2010,
Erik Vollebregt
Just before the holidays the Commission has issued guidelines on an issue that suffers a lot from the lack of harmonisation in the EU: clinical investigation for medical devices. Now that the…